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Grace Medical, Inc.

United States·US-MF-000026047

Last updated September 17, 2026

Information

Country: United States
Address: 8500 Wolf Lake Drive, Memphis, United States
Website: gracemedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(866)472-2363
PRRC Contact: Thomas Fearnley
EUDAMED SRN: US-MF-000026047
FDA FEI Number: 1000022662
DUNS Number: 030849173

Catalogue (1029)

Page 2 of 21

Device	Model / Reference	Registries	Class	Status
Beveled Bobbin Vent Tube	525-172	FDA UDI	Class II	Active
DragonFly™ BUR, DMD, RD, 120MM L, 0.7MM Ø	951-120-007	FDA UDI	Class I	Active
Donaldson Vent Tube	520-051	FDA UDI	Class II	Active
Grace Medical Fluoroplastic Piston	408-450	FDA UDI	Class II	Active
Meiti Piston	418-425	FDA UDI	Class II	Active
Centered Alto Concise Partial	655-075	FDA UDI	Class II	Active
Ha Total Prosthesis	100	FDA UDI	Class II	Active
Grace Medical Titanium Round Wire Piston	463-550	FDA UDI	Class II	Active
Dornhoffer Alto Nytebyte Partial	687N	FDA UDI	Class II	Active
Wildcat Pro, 5.00mm L	709-500	FDA UDI	Class II	Active
Bojrab Dissection Needle, Angled 20°	999-DB4	FDA UDI	Class I	Active
Feathervac Flat Ribbon Stapes Seat	906-003	FDA UDI	Class I	Active
Precise Offset Partial	750-250	FDA UDI	Class II	Active
DragonFly™ BUR, CTR, EGG, 80MM L, 2.3MM Ø, BurShield	953-80-023-SL	FDA UDI	Class I	Active
Precise Offset Total	700-700	FDA UDI	Class II	Active
Tiny Tef Vent Tube	520-151	FDA UDI	Class II	Active
Precise Offset Partial 0.5mm L	751-050	FDA UDI	Class II	Active
Grace Medical Straight Vent Tube	520-061	FDA UDI	Class II	Active
Precise Offset Total	700-650	FDA UDI	Class II	Active
Haberman Alto Total Round Head	608	FDA UDI	Class II	Active
Moretz Alto Ha, Left	612-001L	FDA UDI	Class II	Unknown
Suction Dissector, Angled 45°	999-104	FDA UDI	Class I	Unknown
Bojrab Footplate Shoe	638-080	FDA UDI	Class II	Active
Feathervac Disposable Stapes Seat	906-002	FDA UDI	Class I	Active
Armstrong X Vent Tube	525-201	FDA UDI	Class II	Active
Precise Ha Lite Total	720-675	FDA UDI	Class II	Active
Bartels Bucket Handle Offset	428-450	FDA UDI	Class II	Active
DragonFly™ BUR, DMD, RD, 95MM L, 2.3MM Ø, BurShield	951-95-023-SL	FDA UDI	Class I	Active
Grace Medical Fluoroplastic Piston	403-450	FDA UDI	Class II	Active
Lippy Bucket Handle W/Notch	421-400	FDA UDI	Class II	Active
Gantz Alto Total	611B	FDA UDI	Class II	Active
Precise Ha Lite Partial	770-275	FDA UDI	Class II	Active
Bojrab Tiny Triune	510-511	FDA UDI	Class II	Active
Dornhoffer Alto Partial W/Windows	687	FDA UDI	Class II	Unknown
Offset Alto Concise Partial	650-075	FDA UDI	Class II	Unknown
Offset Nano Alto Partial	653	FDA UDI	Class II	Unknown
Robinson Bucket Handle	424-425	FDA UDI	Class II	Active
Total Tilt Top Head Centered	200	FDA UDI	Class II	Active
DragonFly™ BUR, DMD, RD, 100MM L, 0.7MM Ø, RW	951-100-007-RW	FDA UDI	Class I	Active
Donaldson Vent Tube	510-012	FDA UDI	Class II	Active
Cartilage MACROTOME Handle	990-103	EUDAMEDFDA UDI	Class I	Active
Super E Piston	466-425	FDA UDI	Class II	Active
DragonFly™ ANGLED ADAPTOR-15°	950-006-15	FDA UDI	Class II	Active
Titanium Piston	460-500	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	510-022	FDA UDI	Class II	Active
Bobbin Vent Tube	500-026	FDA UDI	Class II	Active
Precise Centered Partial 0.5mm L	765-050	FDA UDI	Class II	Active
Modified Collar Button Vent Tube	510-243	FDA UDI	Class II	Active
Paparella Vent Tube W/Tab	510-051	FDA UDI	Class II	Active
Mini-Reversible Vent Tube	510-152	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 3, 2026	Z-2308-2026	—	open, classified	Due to incorrect functional length on device labeling.